Exceed AD61USMP
GUDID EMTDAD61USMP0
The Exceed microneedling device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. Exceed consists of - Control Unit - Handpiece with handpiece cable - Handpiece Holder - Power Supply - Instructions for Use
MT.DERM GmbH
Electronic cosmetic micro-needling handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional Cosmetic micro-needling electronic handpiece, professional| Primary Device ID | EMTDAD61USMP0 |
| NIH Device Record Key | bfe8c597-d9f7-403a-aa26-d8c4f5900c65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Exceed |
| Version Model Number | AD61USMP |
| Catalog Number | AD61USMP |
| Company DUNS | 329216357 |
| Company Name | MT.DERM GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 54 KiloPascal and 107 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EMTDAD61USMP0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180778
FDA Product Code
| QAI | Powered Microneedle Device |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-24 |
| Device Publish Date | 2018-10-23 |
On-Brand Devices [Exceed]
| EMTDAD61USMP1 | The Exceed microneedling device is intended to create many, very tiny, microscopic punctures in |
| EMTDAD61USMP0 | The Exceed microneedling device is intended to create many, very tiny, microscopic punctures in |
| EMTDAD64201USMP0 | The Exceed microneedling device is intended to create many, very tiny, microscopic punctures in |
Trademark Results [Exceed]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXCEED 98176079 not registered Live/Pending |
RTEO INC. 2023-09-12 |
 EXCEED 97341531 not registered Live/Pending |
Melaleuca, Inc. 2022-03-31 |
 EXCEED 97341530 not registered Live/Pending |
Melaleuca, Inc. 2022-03-31 |
 EXCEED 97341527 not registered Live/Pending |
Melaleuca, Inc. 2022-03-31 |
 EXCEED 90330770 not registered Live/Pending |
Exceed Home Health Care Inc. 2020-11-19 |
 EXCEED 90328501 not registered Live/Pending |
Exceed Home Health Care Inc. 2020-11-18 |
 EXCEED 90106474 not registered Live/Pending |
Spine Wave, Inc. 2020-08-11 |
 EXCEED 90037625 not registered Live/Pending |
Glen Raven, Inc. 2020-07-06 |
 EXCEED 88871836 not registered Live/Pending |
Melaleuca, Inc. 2020-04-14 |
 EXCEED 88871800 not registered Live/Pending |
Melaleuca, Inc. 2020-04-14 |
 EXCEED 88733141 not registered Live/Pending |
WebCE, Inc. 2019-12-19 |
 EXCEED 87723293 not registered Dead/Abandoned |
Uhnder, Inc. 2017-12-15 |
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